Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Emily.AI.
- Who it may be relevant to
- Registry conditions: Chronic Respiratory Failure, Acute Respiratory Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure
Overview
Currently, there is no holistic solution for patients with respiratory diseases that includes oxygenation and management of a patient with respiratory disease, combining dynamic and automatic O2 administration and the detection of clinical worsening, generating a diagnostic suspicion, a management proposal, and notifying the medical team. For device validation, prospective studies will be conducted in patients in respiratory intermediate care units, conventional hospitalization, during physical activity in the hospital setting, and in an out-of-hospital setting. The device will be evaluated in terms of oxygenation efficacy, response time, patient safety, efficiency, versatility, clinical benefit, and adaptability.
Detailed description
There is no doubt about the efficacy of oxygen therapy in the treatment of acute and chronic respiratory failure in different clinical settings. However, its therapeutic dosage is not as strict as that of other treatments. Hypoxemia has been associated with increased mortality in multiple pathologies and clinical situations. Furthermore, the liberal use of oxygen therapy has also demonstrated harmful effects. Therefore, titration of this therapy is necessary. Traditionally, this has been performed manually, although in recent years, new devices have been developed to automatically adjust O2 flow rates to the needs of each patient, with the goal of maintaining stable oxygen saturations. These systems have the potential to reduce medical error, improve morbidity and mortality, and reduce care costs.
This study is a clinical investigation using a non-CE marked medical device, prospectively validating the device's functional status. The objective is to evaluate its efficacy and safety in patients with respiratory failure, both in hospital and outpatient settings.
Interventions
- Device Emily.AI
EMILY.AI is composed of an O2 regulating valve together with an intelligent system which allows the automation in the regulation of O2 and its customization.
Primary outcome measures
- EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS [Time frame: From enrollment to the end of treatment at 8 hours.]
Secondary outcome measures (5)
- ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS [Time frame: From enrollment to the end of treatment at 8 hours.]
- ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS [Time frame: From enrollment to the end of treatment at 8 hours.]
- ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM [Time frame: From enrollment to the end of treatment at 8 hours.]
- EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION [Time frame: From enrollment to the end of treatment at 8 hours.]
- VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS [Time frame: From enrollment to the end of treatment at 8 hours.]
Eligibility criteria
Inclusion criteria
- Men and women over 18 years of age.
- Admitted to intermediate respiratory care unit with a diagnosis of acute respiratory failure for at least 8 hours.
- Informed consent understood and signed.
Exclusion criteria
- Hemodynamic instability.
- Severe temperature changes.
- Hemoglobinopathies, severe anemia, severe acidosis, or severe alkalosis.
- Anatomical disturbances.
- Pregnancy or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- Hospital Universitario Fundación Jiménez Díaz — Madrid
- Hospital Universitario Fundación Jiménez Díaz — Madrid
Identifiers
NCT: NCT06952816 · FJD-EMILY-23-02